Breaking News: Innovative Biopharmaceutical 'Aibei Gesiting α Injection' by Evive Biotech Receives Approval in the European Union

In a significant milestone for the pharmaceutical industry, Evive Biotech has achieved a major breakthrough with its innovative biopharmaceutical product, "Aibei Gesiting α Injection." The European Union has granted approval for the product's commercialization and sale, making it the first innovative biopharmaceutical to be authorized for marketing in China, the United States, and the European Union. This groundbreaking achievement highlights the global recognition of Evive Biotech's commitment to pioneering advancements in the field of biopharmaceuticals.

Recently, the European Union Commission issued a "Commission Implementing Decision" approving the market launch and sale of Evive Biotech's innovative biopharmaceutical product, "Aibei Gesiting α Injection" (commercially known as "Ryzneuta®"). This decision is based on the positive review and recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). With this approval, "Aibei Gesiting α Injection" becomes the first domestically developed innovative biopharmaceutical to receive marketing authorization in China, the United States, and the European Union. Furthermore, it marks the first innovative drug approved by the European Union for a Chinese pharmaceutical company in 2024.

Prior to this achievement, Evive Biotech had entered into a commercialization agreement with Zhengda Tianqing, obtaining exclusive intellectual property rights and commercialization rights for "Ryzneuta®" within China. "Aibei Gesiting α Injection" stands out among global G-CSF (granulocyte colony-stimulating factor) therapies as the only product to undergo head-to-head clinical studies comparing both long-acting and short-acting originator products. The drug has met its predefined targets and gained approval for simultaneous market launch in China, the United States, and Europe. Its non-PEG-modified long-acting G-CSF formulation offers improved clinical performance, enhanced safety, and the advantage of early administration.

In May 2023, "Ryzneuta®" received approval from the China National Medical Products Administration for the treatment of adult patients with non-myeloid malignancies who experience febrile neutropenia due to myelosuppressive anticancer therapy. It effectively reduces the incidence of infection associated with febrile neutropenia and was subsequently included in China's national medical insurance drug list for the year 2023. The clinical application of "Ryzneuta®" provides a new option for a wide range of chemotherapy patients in preventing neutropenia, offering earlier administration and greater benefits.

According to IQVIA data, the global G-CSF market reached 4.35 billion USD in the first three quarters of 2023, with Europe accounting for 1.06 billion USD. G-CSF drugs are essential for patients experiencing neutropenia after receiving anticancer treatments and are recommended as the primary therapy in guidelines such as ASCO and NCCN.

Evive Biotech's achievement of securing approval for the commercialization and sale of "Aibei Gesiting α Injection" in the European Union marks a significant milestone in the biopharmaceutical industry. Its status as the first innovative biopharmaceutical to be approved for marketing in China, the United States, and Europe underscores the company's dedication to advancing healthcare through groundbreaking therapies. With its superior clinical performance and safety profile, "Aibei Gesiting α Injection" is poised to make a significant impact on patients' lives globally, revolutionizing the treatment landscape for neutropenia and setting a new standard for biopharmaceutical innovation.